NCT02892513

Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain management regimens. However, they come at a cost with profound impacts on gastrointestinal motility, respiratory depression, and even long-term dependence. Stimulating the external ear with cutaneous electrical current is similar to acupuncture and could help improve postoperative pain. The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]), has been used with success in treating opioid withdrawal and in animal studies has shown increases in pain thresholds. The investigators propose a prospective, randomized, placebo-controlled, double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain and reduces opioid requirements for patients undergoing elective colon surgery. pain perception in post-operative patients may be modulated via the auricular branch of the vagus nerve. This has the potential to reduce the use of opioid medications, which will in turn reduce the incidence of postoperative ileus and reduce patient need for and dependence on narcotic pain medications. This would have an enormous economic impact due to decreased length of hospital stays for patients who undergo abdominal surgery. In addition, opioid reduction could potentially lessen the national crisis of opioid addiction.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Percutaneous auricular neurostimulation	The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
DEVICE	Sham percutaneous auricular neurostimulation	Identical in appearance to active, device, but no stimulation will be given.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2016-09-08
• Last updated: 2019-05-07
• Results posted: 2019-05-07

Locations

1 site across 1 country: United States